High Court Punts on Two Life Sciences Cases


Patent lawyers shouldn’t look to the U.S. Supreme Court for any additional guidance on diagnostic method patents or the contours of the Hatch-Waxman Act’s safe harbor.

That’s because the high court refused to take up petitions from the Cleveland Clinic Foundation or Classen Immunotherapies Inc.

The high court declined to review a decision from the U.S. Court of Appeals for the Federal Circuit invalidating three Cleveland Clinic Foundation patents on methods to test for arterial damage. The tests detect the presence of an enzyme the body releases when there is arterial damage or inflammation.

Inventions that are directed to natural phenomenon aren’t eligible for patent protection unless there is an inventive concept, which the patents didn’t have, the appeals court said.

The Cleveland Clinic case illustrates the difficulties in getting patents on medical diagnostic methods.

The high court’s failure to take up the Cleveland Clinic’s petition for review in the Cleveland Clinic Foundation v. True Health Diagnostics case means an already murky area of patent law will remain murky for now. It also means continued obstacles for biotechnology innovators who could have more difficulty attracting investment because of the uncertainties surrounding getting patents on their inventions.

The high court also refused to take up Classen Immunotherapies Inc.'s invitation to review a case involving whether Perrigo PLC subsidiary Elan Pharmaceuticals Inc.'s provision of information on the safety and efficacy of its muscle relaxant to the FDA infringed a Classen patent.

In that case, the U.S. District Court for the District of Maryland, on remand from the Federal Circuit, ruled Elan's provision of information on the safety and efficacy of Skelaxin to the FDA fell within the safe harbor provision. The information submission related to a revision to Skelaxin's product label and proposed changes to the approval requirements for generic versions of the drug.

The Hatch-Waxman Act's safe harbor is important to companies on both sides of pharmaceutical patent litigation because it can exempt from infringement liability any activity that's “reasonably related to the development and submission of information” to the Food and Drug Administration. The harbor is typically used by generic companies that perform certain activities prior to the market launch of their products.

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